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Feasibility Study of the Hemolung Respiratory Assist System (Germany)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01021605
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Alung Technologies

Tracking Information
First Submitted Date  ICMJE November 25, 2009
First Posted Date  ICMJE November 30, 2009
Last Update Posted Date September 30, 2019
Study Start Date  ICMJE December 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • The ability of the Hemolung to remove a minimum of 50 mL/min of CO2 for up to seven days and reliable performance of the device over the length of use [ Time Frame: 7 days ]
  • The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy. [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of the Hemolung Respiratory Assist System (Germany)
Official Title  ICMJE A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure
Brief Summary The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) in patients with hypercapnic respiratory failure.
Detailed Description

The objective of the feasibility study is to evaluate the safety and efficacy of the Hemolung RAS in patients with hypercapnic respiratory failure in five groups of patients:

Group 1: COPD patients with an acute exacerbation and have a 50% likelihood of failure of noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical ventilation

Group 2: Patients with hypercapnic respiratory failure on invasive mechanical ventilation who have either:

  • Failed two or more weaning attempts OR
  • Failed one or more weaning attempts and do not wish to be invasively mechanically ventilated.

Group 3: Patients with hypercapnic respiratory failure on noninvasive positive pressure ventilation who have failed two weaning attempts and do not wish to be invasively mechanically ventilated.

Group 4: Patients with hypercapnic respiratory failure who in the view of the treating physician are declining on optimized non-invasive positive pressure ventilation OR demonstrate a complete intolerance of non-invasive positive pressure ventilation for any reason and invasive mechanical ventilation is considered undesirable by the treating physician.

Group 5: Patients who are currently invasively mechanically ventilated and in the view of the treating physician would benefit from the application of protective lung ventilation, and in whom this cannot be achieved without significant worsening of respiratory failure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercapnic Respiratory Failure, COPD, ARDS
Intervention  ICMJE Device: Hemolung Respiratory Assist System
Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive or invasive ventilation and then the Hemolung RAS. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
Study Arms  ICMJE Experimental: Hemolung Respiratory Assist System
Intervention: Device: Hemolung Respiratory Assist System
Publications * Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2019)
21
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed hypercapnic respiratory failure (PaCO2 >50mmHg(6.7kPa)) and falling into one of the five groups
  • Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O)
  • Hemodynamically stable: Mean arterial pressure (MAP) > 65 mmHg without vasopressor support, or MAP > 60 mmHg with a requirement for vasopressor support that can be attributed to sedation or dynamic hyperinflation resulting from mechanical ventilation by the treating investigator.
  • Chronic arrhythmias (e.g., atrial fibrillation) well controlled
  • Minimum platelet count of 100,000/mm3
  • Minimum red blood cell count of 2.5 mill/μl

Group 1:

  • Known or suspected severe COPD, as defined by the GOLD criteria
  • On non-invasive positive pressure mechanical ventilation > 1hour with either:
  • PaCO2 > 55 mmHg with pH < 7.25 OR
  • PaCO2 > 55 mmHg with < 5mmHg decrease from baseline and pH < 7.30

Group 2:

  • Intubated or tracheostomized patients with hypercapnic respiratory failure who either:
  • Has failed at least 2 weaning attempts or
  • Has failed at least 1 attempt and wishes not to be invasively mechanically ventilated

Group 3:

  • Patient on NIPPV due to hypercapnic respiratory failure who has failed at least 2 weaning attempts and has refused intubation

Group 4:

  • Patients with hypercapnic respiratory failure who are failing optimal NIPPV or demonstrate a complete intolerance to NIPPV and IMV is considered undesirable

Group 5:

  • Patients who are on IMV and would benefit from the application of lung protective ventilation, and in whom this would not be achieved without significant worsening of respiratory failure
  • On IMV for at least 12 hours
  • pH <7.30 due to respiratory acidosis

Exclusion Criteria:

  • Presence of acute, uncontrolled arrhythmia
  • Acute ischemic heart disease
  • Presence of bleeding diathesis
  • Significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder
  • Recent (< 7 days) prolonged (>24 hrs) use of muscle paralyzing agents
  • Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation
  • Coma from any cause, or decreased consciousness
  • Hypersensitivity to heparin or previous heparin induced thrombocytopenia
  • Recent (< 6 months) major chest abdominal trauma or surgery
  • Presence of septic shock
  • Presence of a significant pneumothorax or bronchopleural fistula
  • History of uncontrolled major psychiatric disorder
  • Pregnant women
  • Known to have AIDS or to have symptomatic HIV
  • Received chemotherapy or radiation within the previous 90 days
  • Received an organ transplant other than corneal transplants
  • Received or currently receiving immunosuppressive therapy, excluding corticosteroids within the last 3 months
  • Presence of severe renal or liver failures
  • Known vascular abnormality which would complicate or prevent successful insertion of the vascular access catheter in either the right internal jugular vein or right femoral vein
  • Presence of another catheter in both the right internal jugular vein and right femoral vein that cannot be moved to allow insertion of the Hemolung catheter in one of these vessels.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01021605
Other Study ID Numbers  ICMJE HL-CA-1000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alung Technologies
Study Sponsor  ICMJE Alung Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Felix JF Herth, MD Thoraxklinik-Heidelberg gGmbH
PRS Account Alung Technologies
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP